Development of an Intelligent Balance Training System Providing Weight-bearing Feedback in Stroke Patients

Stroke Clinical Trial

Official title:

Development of an Intelligent Balance Training System Providing Weight-bearing Feedback Via Force Platform to Improve Sit-to-stand, Dynamic Weight-shifting and Standing Performance in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04841161
• Other study ID #: KMUHIRB-F(II)-20150033
• Status: Completed
• Phase: N/A
• Start date: February 25, 2016
• Est. completion date: September 19, 2018

Study information

• Verified date: February 2021
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The sit-to-stand and dynamic weight-shifting ability of stroke patients is highly associated with walking performance. Therefore, in order to improve the dynamic weight-shifting ability in sit-to-stand and parallel or tandem standing, a real-time visual or auditory feedback is used in our design to allow patients to realize the weight-bearing condition (by using load cells) in both sound and affected legs immediately. It can help patients to learn to control muscle to shift weight effectively which will improve patients' walking performance. By integrating physical therapy planning with electro-mechanical technology, the goal of this study is to develop a standing balance training system by requiring patients to control their center of pressure (COP) in performing sit-to-stand and maintain a standing posture via the use of their core and lower extremity musculature.

Description:

1. Written informed consent must be obtained before any study specific procedures are undertaken.

1. For healthy group: Participants will be recruited from the staffs and students in Kaohsiung Medical University (including Learning University), and healthy families of CVA patients in the university affiliated hospital.

2. For stroke (CVA) group: We will ask the physical therapists in the university affiliated hospital to nominate the potential CVA participants . The physicians will determine if they would meet the inclusion criteria before participating the present study.

2. The process of the experiment (brief describe)

1. Written informed consent must be obtained before any study specific procedures are undertaken.

2. Subjects who are recruited to participate in this experiment should provide the personal information forms first (ex: sex, age, height, weight, post-stroke duration, stroke type, hemiplegic side, ambulation devices etc.). Then, assessment (PASS, Berg Balance Scale, Timed Up and Go) will be conducted by a physical therapist at baseline.

3. While the stroke patients after completing the 4 -times, and 8-times training program, the above-mentioned assessment conducted again by the same physical therapist. The healthy will not receive balance training, thus .only receive one assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 19, 2018
• Est. primary completion date: September 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Healthy adults

a. Their age should be ranged between 20 - 75 years

2. Stroke patients

1. diagnosed with unilateral ischemic or hemorrhagic stroke

2. a minimum of six months post stroke

3. able to stand without support for 1 minutes

4. medically stable with physician release

Exclusion Criteria:

1. Healthy adults

1. neurological diseases

2. musculoskeletal diseases

3. rheumatic diseases

4. history of orthopedic surgery on spine or lower extremity

2. Stroke patients

1. other injuries or illnesses that affect standing or walking

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Balance function, gait ability, weight- distribution and weight-shifting
Healthy adults and stroke patients accepted two measurements within a week. Balance function, gait ability, weight- distribution and weight-shifting during sit-to-stand, quite standing, and weight-shifting toward the forward foot.
• Weight- distribution and weight-shifting training program
The stroke patients received a weight-shifting training program , 30 minutes/time, 2-5 days a week for 2-3 weeks(8 sessions). After training, they accepted a post-test within a week.

Locations

Country	Name	City	State
Taiwan	Li-Jiun Liaw	Kaohsiung City	Sanmin Dist

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in performance of weight distribution after 8 sessions intervention	By using the force plate to record the ground reaction force and then to obtain weight distribution while performing the sit to stand activity	The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Primary	Changes in performance of standing balance after 8 sessions intervention	By using the force plate to obtain displacements of the center of pressure (COP) while standing and weight transfer	The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Primary	Changes in performance of static and dynamic balance after 8 sessions intervention	By using the Postural Assessment Scale of Stroke (PASS) to assess and monitor postural control. The PASS consists of 2 sections with a 4-point scale to describe each task. The total score ranges from 0 - 36.	The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Primary	Changes in performance of balance function after 8 sessions intervention	By using the Berg Balance Scale to assess balance function. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4during a series of predetermined tasks. The total score ranges from 0 - 56.	The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Primary	Changes in performance of dynamic balance after 8 sessions intervention	By using Timed Up and Go Test (TUG) to assess fall risk and measure the progress of balance. An older adult who takes =12 seconds to complete the TUG is at risk for falling.	The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)